01 1Alcaftadine
02 1Bexarotene
03 1Bortezomib
04 1Bromfenac Sodium
05 1Busulfan
06 1Cevimeline Hydrochloride
07 1Clofarabine
08 1Cyclophosphamide
09 1Dacarbazine
10 2Degarelix Acetate
11 1Dimetindene
12 1Enasidenib
13 1Felbamate
14 2Ferric Carboxymaltose
15 1Ferumoxytol
16 2Flibanserin
17 1Ganirelix
18 1Itraconazole
19 1Linaclotide
20 1Lurbinectedin
21 1Methyltyrosine
22 1Miglustat
23 1Nadolol
24 1Pantoprazole Sodium
25 1Penicillamine
26 1Perphenazine
27 1Phentolamine Mesylate
28 1Plerixafor
29 1Ponatinib
30 1Protriptyline
31 1Safinamide Mesylate
32 1Sarecycline
33 1Selegiline Hydrochloride
34 1Selexipag
35 1Semaglutide
36 1Sugammadex Sodium
37 1Sulfiram
38 1Talazoparib
39 1Tirzepatide
40 1Trabectedin
41 1Voriconazole
42 5Blank
01 28Active
02 3Inactive
03 18Blank
01 4Valid
02 45Blank
01 1231MF10057
02 48Blank
01 13WC-0110n
02 36Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-22
Pay. Date : 2013-09-20
DMF Number : 22922
Submission : 2009-06-30
Status : Active
Type : II
Registration Number : 231MF10057
Registrant's Address : 49 Napoleon Ct. , Somerset, NJ 08873, USA
Initial Date of Registration : 2019-02-25
Latest Date of Registration :
NDC Package Code : 14096-140
Start Marketing Date : 2009-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-10
Pay. Date : 2015-05-27
DMF Number : 23924
Submission : 2010-08-05
Status : Active
Type : II
Certificate Number : R1-CEP 2016-270 - Rev 00
Issue Date : 2023-05-17
Type : Chemical
Substance Number : 542
Status : Valid
NDC Package Code : 14096-147
Start Marketing Date : 2011-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39948
Submission : 2024-06-07
Status : Active
Type : II
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0110n
Address of the Firm :
NDC Package Code : 42973-194
Start Marketing Date : 2012-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-13
Pay. Date : 2021-06-07
DMF Number : 35828
Submission : 2021-04-19
Status : Active
Type : II
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0110n
Address of the Firm :
NDC Package Code : 42973-310
Start Marketing Date : 2020-12-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35114
Submission : 2020-09-04
Status : Active
Type : II
Certificate Number : CEP 2022-362 - Rev 00
Issue Date : 2024-08-02
Type : Chemical
Substance Number : 2576
Status : Valid
NDC Package Code : 73223-005
Start Marketing Date : 2019-08-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32382
Submission : 2018-01-07
Status : Active
Type : II
NDC Package Code : 42973-204
Start Marketing Date : 2017-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-08-07
Pay. Date : 2015-07-29
DMF Number : 23631
Submission : 2010-04-26
Status : Active
Type : II
NDC Package Code : 14096-150
Start Marketing Date : 2009-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0110n
Address of the Firm :
NDC Package Code : 42973-144
Start Marketing Date : 2008-11-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0110n
Address of the Firm :
NDC Package Code : 42973-228
Start Marketing Date : 2017-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0110n
Address of the Firm :
NDC Package Code : 42973-173
Start Marketing Date : 2011-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
